Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma

Phase
Recruitment status
Participants
Lead sponsor
Start date
Number of sites

Summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.
Short title
Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma
Official title
Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)

    Timeframe: Up to Approximately 56 Days

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

  2. Number of Participants with Adverse Events (AE)s

    Timeframe: Up to Approximately 129 Months

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  1. Partial Response (PR) Response Rate (RR)

    Timeframe: Up to 3 Years

    PR is defined \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a \>= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a \>= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>= 30%, \>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline.

  2. Very Good Partial Response (VGPR) RR

    Timeframe: Up to 3 Years

    VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein plus urine M-protein \< 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as \>= 90% decrease in the difference between involved and uninvolved FLC levels.

  3. Complete Response (CR) RR

    Timeframe: Up to 3 Years

    CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio is also required.

  4. Stringent Complete Response (sCR) RR

    Timeframe: Up to 3 Years

    sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio \<= 4:1 or \>= 1:2 for kappa and lambda participants, respectively, after counting \>= 100 plasma cells).

  5. Overall Response Rate (ORR)

    Timeframe: Up to 3 Years

    ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better.

  6. Progression-Free Survival (PFS)

    Timeframe: Up to 3 Years

    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.

  7. Duration of Response (DOR)

    Timeframe: Up to 3 Years

    DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.

  8. Time-to-Progression (TTP)

    Timeframe: Up to 3 Years

    TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.

  9. Minimal Residual Disease (MRD) negativity

    Timeframe: Up to 3 Years

    The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status.

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1.
  • Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
  • All participants must have measurable diseases per central laboratory as outlined in protocol

  • Has received prior etentamig treatment.
  • Prior exposure to BCMA-targeted therapy as noted in the protocol.
  • Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
Sources for eligibility

  • Beverly Hills Cancer Center /ID# 266921Beverly Hills, United StatesRecruiting
  • Colorado Blood Cancer Institute /ID# 273751Denver, United StatesRecruiting
  • Washington University /ID# 266972St Louis, United StatesRecruiting
  • Rutgers Cancer Institute of New Jersey /ID# 266833New Brunswick, United StatesRecruiting
  • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282New York, United StatesRecruiting
  • University Of North Carolina Health Care - Hillsborough Campus /ID# 278230Hillsborough, United StatesRecruiting
  • Swedish Medical Center - Seattle /ID# 268052Seattle, United StatesRecruiting
  • Blacktown Hospital /ID# 265983Blacktown, AustraliaRecruiting
  • Wollongong Hospital /ID# 265625Wollongong, AustraliaRecruiting
  • The Alfred Hospital /ID# 265981Melbourne, AustraliaRecruiting
  • Austin Hospital /ID# 265984Melbourne, AustraliaRecruiting
  • Sir Charles Gairdner Hospital /ID# 265985Nedlands, AustraliaRecruiting
  • University Health Network_Princess Margaret Cancer Centre /ID# 275636Toronto, CanadaRecruiting
  • Jewish General Hospital /ID# 267574Montreal, CanadaRecruiting
  • Chu de Nice-Hopital Larchet Ii /Id# 266845Nice, FranceRecruiting
  • Hôpital La Timone /ID# 267053Marseille, FranceRecruiting
  • Chu De Lille - Hopital Claude Huriez /ID# 270193Lille, FranceRecruiting
  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694Tours, FranceRecruiting
  • IUCT Oncopole /ID# 266391Toulouse, FranceRecruiting
  • National Cancer Center Hospital East /ID# 268343Kashiwa-shi, JapanRecruiting
  • Kumamoto University Hospital /ID# 270530Kumamoto, JapanRecruiting
  • Dokkyo Medical University Hospital /ID# 271648Mibu, JapanRecruiting
  • Nippon Medical School Hospital /ID# 270254Bunkyo-ku, JapanRecruiting
  • The Cancer Institute Hospital Of JFCR /ID# 268342Koto-ku, JapanRecruiting
  • Amsterdam UMC, Location VUmc /ID# 267670Amsterdam, NetherlandsRecruiting

And 2 more, listed on the interactive page.

Sources for sites

Other registry identifiers

  • 2024-512146-41-00
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (4)